Clinical Core

临床核心

• 批准号: 10419277
• 负责人: Kari C. Nadeau
• 金额: $ 30.97万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-07 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10419277
• 关键词: Ablation; Address; Adherence; Adjuvant; Adult; Africa; Algorithms; Allergic Disease; Allergic Reaction; Antibiotics; Antigens; Aspirate substance; Automobile Driving; Award; B-Lymphocytes; Bioinformatics; Biological Assay; Biological Markers; Blood; Bone Marrow; COVID-19 vaccine; Cataloging; Cells; Clinical; Clinical Immunology; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Communication; Computer Models; Cytometry; Data; Data Analyses; Data Security; Data Storage and Retrieval; Databases; Development; Ensure; Exposure to; Fine needle aspiration biopsy; Goals; Good Clinical Practice; Guidelines; Hospitals; Human; Human Resources; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Influenza; Informatics; Infrastructure; Institutional Review Boards; Investigation; Longitudinal Studies; Measures; Messenger RNA; Molecular Profiling; Monitor; National Institute of Allergy and Infectious Disease; Natural Immunity; Nature; Performance; Pfizer-BioNTech COVID-19 vaccine; Plasma; Population; Practice Guidelines; Predisposition; Procedures; Process; Protocols documentation; Quality Control; RNA vaccine; Rabies; Recombinants; Reporting; Research; Research Personnel; Research Project Grants; Role; Sampling; Saponins; Services; South African; Special Population; Specimen; Standardization; System; T cell response; T-cell receptor repertoire; Technology; Time; Training; Translational Research; United States National Institutes of Health; Update; Vaccination; Vaccines; Validation; Work; adaptive immunity; antigen-specific T cells; base; biological systems; cytokine; data integration; data management; data submission; epigenomics; expectation; human subject; human subject protection; improved; influenza virus vaccine; metabolomics; microbiome; microbiota; multiple omics; new technology; novel; public database; recruit; response; sample collection; search engine; seasonal influenza; single cell analysis; transcriptomics; vaccine development; vaccinology

1 ABSTRACT – Clinical Core 2 The Clinical Core of the Stanford HIPC U19 will provide state-of-the-art clinical and biospecimen support for all 3 the research projects, the Immune Monitoring and the Data Management and Analysis Cores, as well as the 4 expertise, facilities, personnel, procedures and processes for the implementation and conduct of the proposed 5 clinical projects. The Clinical Core will provide and update processes and training for clinical investigators and 6 staff; organize, implement, monitor and work to improve clinical project performance; and conduct quality control 7 and corrective action and handle protocol deviations (if needed), including assuring adherence to milestones, 8 project performance expectations, standardized approach in the recruitment and clinical characterization, 9 appropriate human subject protection measures and clinical Good Practice Guidelines. The Clinical Core will 10 provide the clinical research units which include the infrastructure for longitudinal studies: recruitment, retention, 11 data entry and data management, quality review, sample collection (blood, fine needle aspiration (FNA) and 12 bone marrow (BM) aspirates) processing, isolation and cataloging of various specimen types and will oversee 13 all regulatory-related documents and IRB compliant research. The Clinical Core will coordinate clinical 14 biospecimen storage informatics, connecting clinical, biospecimen management, and assay pipelines into a 15 cutting-edge search engine and analysis platform for clinical and translational research. The Clinical Core will 16 be led by Dr. Kari Nadeau with Associate Director Dr. Nadine Rouphael, Dr. Long at UCSF, and Drs. Madhi and 17 Nunez at hospitals in S. Africa. The Clinical Core will work closely with the other cores and projects to enable 18 the functional analysis of any samples with cutting-edge technologies. Drs. Nadeau, Rouphael, Long, Madhi, 19 and Nunez and their teams have the expertise to be able to comprehensively serve as the Clinical Core 20 personnel since they have been successful in other NIH related consortium studies, in performing Clinical Core 21 duties for other immunology clinical studies, and have worked with Drs. Pulendran, Davis, Maecker, Khatri and 22 Boyd for over 15 years. The Core Leader will represent the HIPC center in a HIPC Clinical Sub-Committee that 23 will operate under the HIPC Coordinating Center to promote cross-HIPC collaboration including sharing SOPs, 24 documents, and samples as appropriate. The Clinical Core proposes the following aims: (1) To perform clinical 25 studies with COVID-19 vaccines, and on the impact of the microbiome on rabies vaccination, to provide clinical 26 data and samples to accomplish the scientific goals of the research projects; (2) Establish and maintain 27 personnel training, procedures, and processes to provide core clinical support; and (3) Establish and maintain 28 protocol milestones, performance guidelines, communication strategies, and compliance in clinical studies and 29 sample collection. In summary, the Clinical Core will leverage state-of-the-art biospecimen support services and 30 will coordinate all operational and regulatory aspects of research for the HIPC U19 projects. 31

1 摘要 – 临床核心 2 斯坦福 HIPC U19 的临床核心将为所有患者提供最先进的临床和生物样本支持 3 研究项目，免疫监测和数据管理和分析核心，以及 4 实施和进行拟议项目的专业知识、设施、人员、程序和流程 5 个临床项目将为临床研究人员提供并更新流程和培训。 6名工作人员；组织、实施、监控和改进临床项目绩效并进行质量控制； 7、纠正措施并处理协议偏差（如果需要），包括确保遵守里程碑， 8 项目绩效预期、招募和临床特征的标准化方法、 9 适当的人类受试者保护措施和临床良好实践指南将。 10 提供临床研究单位，其中包括纵向研究的基础设施：招募、保留、 11 数据输入和数据管理、质量审查、样本采集（血液、细针抽吸 (FNA) 和 12 骨髓（BM）抽吸）各种样本类型的处理、分离和编目，并将监督 13 临床核心将协调所有监管相关文件和 IRB 合规研究。 14 个生物样本存储信息学，将临床、生物样本管理和分析管道连接到一个 15 个用于临床和转化研究的尖端搜索引擎和分析平台。 16 由 Kari Nadeau 博士和副主任 Nadine Rouphael 博士、UCSF 的 Long 博士以及 Madhi 和 Drs. 领导。 17 南非医院的 Nunez 临床核心将与其他核心和项目密切合作，以实现这一目标。 18 使用尖端技术对任何样品进行功能分析。 19 和 Nunez 及其团队拥有能够全面充当临床核心的专业知识 20 名人员，因为他们在其他 NIH 相关联合研究中取得了成功，执行了临床核心 21 项其他免疫学临床研究职责，并与 Pulendran、Davis、Maecker、Khatri 和 Drs 合作。 22 Boyd 的核心领导者将在 HIPC 临床小组委员会中代表 HIPC 中心。 23 将在重债穷国协调中心下运作，以促进跨重债穷国合作，包括共享标准操作程序、 24 份文件和适当的样本。临床核心提出以下目标： (1) 进行临床。 25 项有关 COVID-19 疫苗以及微生物组对狂犬病疫苗接种影响的研究，旨在为临床提供帮助 完成研究项目科学目标的26个数据和样本（2）建立和维护； 27 提供核心临床支持的人员培训、程序和流程；以及 (3) 建立和维护； 临床研究和临床研究中的 28 个方案里程碑、绩效指南、沟通策略和合规性 29 样本收集 总之，临床核心将利用最先进的生物样本支持服务和 30 将协调 HIPC U19 项目研究的所有运营和监管方面。 31